Effect of Rocuronium and Sugammadex Under Sevoflurane and Desflurane Anesthesia in Children

NCT03795259 | Completed DMC

• 1 other identifier: 83045809-604.01
• Study Type: interventional
• Target: 148
• Locations: 1 country
• Sites: 1

Brief Summary

Sugammadex is the first selective relaxant binding agent approved to reverse certain non-depolarizing neuromuscular drugs in patients 2 years old and above. Although it has been in use over the last 10 years, more pharmacological studies are needed to understand its overall effects on participants. As investigators' primary outcome, the investigators aimed to investigate how differently sugammadex reverses neumuscular blockade caused by rocuronium under general anesthesia maintenance with sevoflurane compared with desflurane. Also, to compare the changes in peak airway pressure. As investigators' secondary outcome, the investigators aimed to compare the changes in heart rate and blood pressures after sugammadex injection under sevoflurane and desflurane general anesthesia.

Conditions

Anesthetics, Inhalation; Neuromuscular Blockade; Anesthesia, General

Keywords

Sugammadex; Sevoflurane; Desflurane; Rocuronium; TOF; Child; Train-of-four

Outcome Measures

Primary Outcomes (4)

• Time from TOF of 25% to 90% after 2 mg/kg sugammadex injection

  When the TOF value reaches 25% from 0% after the anesthesia induction, 2 mg/kg sugammadex will be given to reverse neuromuscular blockade. Continuous TOF monitoring will continue every 15 seconds. The time it takes for TOF to reach 90% is the primary outcome.

  Up to end of surgery

• Time from TOF of 100% to 0% after 0.6 mg/kg rocuronium injection

  After induction of anesthesia a baseline TOF will be recorded (anticipated 100%). 0.6 mg/kg rocuronium will be injected and TOF will be measured every 15 seconds. The time it takes for TOF to reach 0% is the second primary outcome.

  Up to end of surgery

• Time from TOF of 0% to 25% after orotracheal intubation

  After TOF reaches 0%, orotracheal intubation will be performed. Continuous TOF monitoring will be done every 5 minutes in first 15 minutes and every 15 seconds afterwards. No additional neuromuscular blocking drugs will be given. The time it takes for TOF to reach 25% is the third primary outcome.

  Up to end of surgery

• Sugammadex effects on respiratory parameters

  Peak airway pressure observed at and after sugammadex injection at 1st, 2nd, 3rd and 10th minutes.

  Up to 10 minutes post-administration of study intervention

Secondary Outcomes (3)

• Sugammadex effects on heart rate

  Up to 10 minutes post-administration of study intervention

• Sugammadex effects on systolic and diastolic blood pressures

  Up to 10 minutes post-administration of study intervention

• Percentage of Participants Experiencing an Adverse Event (AE) after Administration of Study Intervention

  Intraoperative and postoperative first 24 hour.

Study Arms (2)

Sevoflurane

ACTIVE COMPARATOR

Anesthesia will be induced with thiopenthal 5-6 mg/kg and fentanyl 2 mcg/kg. Then rocuronium 0.6 mg/kg will be given by intravenously and patients will be orotracheal intubated when TOF value reaches 0%. Anesthesia will continue with 2% sevoflurane while the patient is ventilated in volume controlled mode (FiO2: 40%, I/E: 1/1.5, PEEP: 5 cmH2O, tidal volume: 8ml/kg). Continuous TOF measurement will continue until the value reaches %25. At this time, sugammadex 2 mg/kg will be given to measure the time for TOF to reach 90%.

Drug: Rocuronium; Drug: Sugammadex

Desflurane

ACTIVE COMPARATOR

Anesthesia will be induced with thiopenthal 5-6 mg/kg and fentanyl 2 mcg/kg. Then rocuronium 0.6 mg/kg will be given by intravenously and patients will be orotracheal intubated when TOF value reaches 0%. Anesthesia will continue with 6% desflurane while the patient is ventilated in volume controlled mode (FiO2: 40%, I/E: 1/1.5, PEEP: 5 cmH2O, tidal volume: 8ml/kg). Continuous TOF measurement will continue until the value reaches %25. At this time, sugammadex 2 mg/kg will be given to measure the time for TOF to reach 90%.

Drug: Rocuronium; Drug: Sugammadex

Interventions

Rocuronium DRUG

After induction, rocuronium 0.6 mg/kg will be given by intravenously and patients will be orotracheal intubated when TOF value reaches 0%.

Also known as: Esmeron, MSD

Desflurane; Sevoflurane

Sugammadex DRUG

Continuous TOF measurement will continue until the value reaches %25. At this time, sugammadex 2 mg/kg will be given intravenously.

Also known as: Bridion, MSD

Desflurane; Sevoflurane

Eligibility Criteria

• Age: 2 Years - 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Lower urinary tract surgery (cystoscopy, examination under general anaesthesia, circumcision etc.) and inguinal hernia surgery expected no to last more than 2 hours
• ASA I-II

You may not qualify if:

• Liver and failure
• Upper airway infection
• Asthma
• Exposure to second hand smoke
• Kidney failure
• Obesity (BMI\> 30%)
• Rocuronium allergy
• Muscle disease (myasthenia gravis, muscular dystrophies, etc.)
• Calcium channel blocker use
• Patient or family refusal

Sponsors & Collaborators

• Istanbul University: lead
• GAMZE PİRİNÇ ŞAŞIOĞLU: collaborator
• GÜNER KAYA: collaborator
• Ayse Cigdem Tutuncu: collaborator

Study Sites (1)

Istanbul University Cerrahpasa Medical Faculty

Istanbul, Please Select, 34098, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Respiratory Aspiration

Interventions

Rocuronium; Sugammadex

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Androstanols; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; gamma-Cyclodextrins; Cyclodextrins; Macrocyclic Compounds; Dextrins; Starch; Glucans; Polysaccharides; Carbohydrates

Study Officials

• Guner Kaya, Prof.

  Istanbul University Cerrahpasa Medical Faculty

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, Principal investigator

Study Record Dates

• First Submitted: December 27, 2018
• First Posted: January 7, 2019
• Study Start: December 28, 2018
• Primary Completion: May 19, 2019
• Study Completion: May 19, 2019
• Last Updated: May 4, 2021

Record last verified: 2021-04

Locations

TU (1)